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Senior Quality Engineer

Company: Itw
Location: Hebron
Posted on: January 12, 2022

Job Description:

Company Description

ITW Medical manufactures and sells components and finished devices for use in medical Imaging, Filtration, Infusion, and Minimally Invasive applications.

ITW Medical is comprised of three strong medical product brands - Coeur, Filtertek & Precise - situated to proactively meet the needs of customers in the marketplace. Coeur is a leading provider of disposable medical products used in diagnostic imaging and other medical procedures. The Filtertek product line is comprised of custom plastic insert molded filtration and flow control components for global OEM medical device customers. Precise Biomedical is a service company providing maintenance and repair of power injectors used for imaging procedures

General Accountability

Job Description

This position will report to ITW Medicals Quality Manager - Hebron. The individual will be responsible for validations, scrap reduction and continuous improvement activities. The individual will ensure that projects are implemented, internal/external quality issues are investigated, and root cause and corrective/preventive actions are identified and executed. This position will be primarily responsible for the Hebron, Ill location.

Duties And Responsibiities

New Product Development

This position will be heavily involved in validation and verification of new products, expanded processes, and continuous improvement in all areas of the business. Given the avalanche of new business, this position will be heavily engaged with customers. In addition to validation protocols and reports, this position will be responsible for Gage MSA.

Participate in creation and maintain Failure Modes and Effects Analysis (FMEA).

Assist in documenting development work including supporting writing specifications for manufacturing, identifying and/or evaluating scientific test results, and working with Design team to ensure Follow-up Drawings are coordinated.

Support Implementation of IQ, OQ, PQ.

Ensure timely and conclusive validation protocol and report writing.

Process Control

Update existing inspection plans, test methods, and standard operating procedures

Conduct sample size determination, statistical analysis, training, and root cause analysis

Assist in process optimization and work with Operations to implement CpKs and use of process controls.

Maintain calibration

Work with Quality, OPS, and Engineering teams and help implement improved ECN Processing

Continuous Improvement

Support and Actively contribute to various manufacturing projects such as process development, cost reduction and quality improvement initiatives

Perform routine engineering assignments of related tasks which are typically a focused portion of larger projects.

Support cross-functional teams in continuous quality improvement projects, in particular, in scrap reduction and identification and elimination of non-value-added activities.

Take lead in collection, review, analysis and trending of quality indicators for monthly and quarterly reviews.

Manage and contribute to problem solving teams using standardized investigation processes/tools. (This includes customer complaint investigation and response.)

Develop understanding of Test Equipment and identify tester upgrades.

Compliance

Participate in the Internal Audit process and assist in addressing observations and support Environmental auditing.

Participate in customer and regulatory body audits

Other tasks and duties assigned

Qualifications

Position Skills and Experience Requirements:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

  • Bachelors degree (required) in Biomedical Engineering field (desired).
  • 5+ years related experience (required) in Medical Devices Industry (preferred).
  • Ability to perform routine design and engineering tasks with some assistance.
  • Solid understanding of engineering and mathematics principles.
  • Expertise in the application of statistics and the ability to talk with customers with a high level of understanding of statistical application and requirements.
  • Successful experience using Sharepoint and other electronic data filing/management/ processing software.
  • Ability to interpret product requirements from drawings, specifications, blueprints, etc. and to identify and drive corrections of inconsistencies or inaccuracies in same
  • Able to command use of inspection and measuring instruments such as calipers, micrometers, and tensile strength testers
  • Highly motivated, detail-oriented, eager to drive needed change in the organization
  • Demonstrated use of strong analytical, problem solving, and teamwork skills in a leadership role
  • Able to follow and to provide instructions in all formats: written, verbal, and electronic.
  • Excellent time management, prioritization abilities, and strong project management skills
  • Ability to develop, implement, and present strategies to gain support
  • Strong analytical skills, with 80/20 mindset
  • Ability to work with and manage complexity/change such that implementation is simplified
  • Demonstrated ability to analyze data and make sound, enterprise-first, decisions
  • Excellent interpersonal, communication, and presentation skills
  • Ability to generate respect and trust from staff and external constituencies along with the ability to work collaboratively with colleagues and staff to create a results-driven, team-oriented, profitable environment
  • Personally driven and able to motivate others to excel
  • Ability to use MS Office Tools such as Word, Excel, Project, Access and MiniTab.
    Additional Information

    Additional Information

    ITW offers a competitive compensation and benefits package, including competitively priced medical and dental coverage the first of the month following hire, free life insurance, paid vacation and holidays, and immediate 401k matching. Additional retirement savings contribution (above and beyond 401k) is awarded at no cost after one year.

    ITW Medical is an equal opportunity, equal employment, affirmative action employer. We strive to create a diverse and inclusive work environment where everyone is welcome to contribute their unique talents and ideas. We encourage applications from females, males, disabled/protected or other veterans, persons with disabilities, all races and ethnicities, sexual orientations and gender identities. Reasonable accommodation will be made to enable persons with disabilities to apply and to perform the essential job functions. If you require assistance with completing an application, please reply that you require assistance.by Jobble

Keywords: Itw, Elgin , Senior Quality Engineer, Engineering , Hebron, Illinois

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